Paranasal sinus access implant devices and related products and methods

Abstract

A paranasal sinus access implant device may include one or more material or geometric features that may enhance performance of one or more portions of the implant device, for example an exposed surface including an antimicrobial agent. Various products and methods may include or use such an implant device.

What is claimed is: 
     
       1. A paranasal access implant device for implantation in a human to fluidly connect a lacrimal apparatus to a paranasal sinus through a fistula formed between the lacrimal apparatus and the paranasal sinus, the implant device comprising:
 a proximal end at a first longitudinal end of the device to be disposed in the lacrimal apparatus when the device is implanted and a distal end at a second longitudinal end of the device to be disposed in the paranasal sinus when the device is implanted; 
 a length longitudinally along the implant device between the proximal end and the distal end in a range of from 8 millimeters to 50 millimeters; 
 a conduit, located between the proximal end and distal end, to be disposed through a fistula between the lacrimal apparatus and the paranasal sinus when the device is implanted, the conduit comprising a distal portion to be disposed in the paranasal sinus when the implant device is implanted; 
 a head located proximal of the conduit, to be disposed in the lacrimal apparatus when the device is implanted; and 
 an internal passage through the head and the conduit, to provide a fluid communication path between the lacrimal apparatus and the paranasal sinus when the device is implanted, the internal passage having a width through at least a portion of the conduit in a range of from 0.25 millimeter to 5 millimeters; 
 and wherein: 
 at least one of the head and the distal portion of the conduit comprises an exposed surface of exposed material, the exposed surface having an average roughness (Ra) in a range of from 1 nanometer to 200 nanometers; 
 the Ra is in a range of from 1 nanometer to 50 nanometers over a continuous surface area of at least 2 square millimeters on the head; 
 the conduit comprises a first material having a first hardness and the head comprises a second material having a second hardness that is smaller than the first hardness; 
 the head comprises a structural portion of the first material and a skin portion supported by the structural portion, the skin portion including the second material; 
 the skin portion has a depth below the exposed surface in a range of from 10 microns to 200 microns; 
 the first material has a hardness in a range of from Shore A 50 durometer to Shore A 100 durometer; and 
 the second material comprises a silicone material or a silicone hydrogel. 
 
     
     
       2. A paranasal sinus access implant device for implantation in a human to fluidly connect a lacrimal apparatus to a paranasal sinus through a fistula formed between the lacrimal apparatus and the paranasal sinus, the implant device comprising:
 a proximal end at a first longitudinal end of the device to be disposed in the lacrimal apparatus when the device is implanted and a distal end at a second longitudinal end of the device to be disposed in the paranasal sinus when the device is implanted; 
 a length longitudinally along the implant device between the proximal end and the distal end in a range of from 8 millimeters to 50 millimeters; 
 a conduit, located between the proximal end and distal end, to be disposed through a fistula between the lacrimal apparatus and the paranasal sinus when the device is implanted, the conduit comprising a distal portion to be disposed in the paranasal sinus when the implant device is implanted; 
 a head located proximal of the conduit, to be disposed in the lacrimal apparatus when the device is implanted; and 
 an internal passage through the head and the conduit, to provide a fluid communication path between the lacrimal apparatus and the paranasal sinus when the device is implanted, the internal passage having a width through at least a portion of the conduit in a range of from 0.25 millimeter to 5 millimeters; 
 and wherein: 
 at least one of the head and the distal portion of the conduit comprises an exposed surface of exposed material, the exposed surface having an average roughness (Ra) in a range of from 1 nanometer to 200 nanometers; 
 the Ra is in a range of from 1 nanometer to 50 nanometers over a continuous surface area of at least 2 square millimeters on the head; 
 at least a portion of the conduit is of a radiopaque material having a radiodensity in a range of from 100 Hounsfield units to 900 Hounsfield units; 
 the conduit has a radiopaque portion made of the radiopaque material, the radiopaque portion of the conduit extending for at least 5 millimeters of a longitudinal length of the conduit; and 
 the head comprises flanged portions having a refractive index across the thickness of the flanged portions of no larger than 1.45. 
 
     
     
       3. A paranasal sinus access implant device for implantation in a human to fluidly connect a lacrimal apparatus to a paranasal sinus through a fistula formed between the lacrimal apparatus and the paranasal sinus, the implant device comprising:
 a proximal end at a first longitudinal end of the device to be disposed in the lacrimal apparatus when the device is implanted and a distal end at a second longitudinal end of the device to be disposed in the paranasal sinus when the device is implanted; 
 a length longitudinally along the implant device between the proximal end and the distal end in a range of from 8 millimeters to 50 millimeters; 
 a conduit, located between the proximal end and distal end, to be disposed through a fistula between the lacrimal apparatus and the paranasal sinus when the device is implanted, the conduit comprising a distal portion to be disposed in the paranasal sinus when the implant device is implanted; 
 a head located proximal of the conduit, to be disposed in the lacrimal apparatus when the device is implanted; and 
 an internal passage through the head and the conduit, to provide a fluid communication path between the lacrimal apparatus and the paranasal sinus when the device is implanted, the internal passage having a width through at least a portion of the conduit in a range of from 0.25 millimeter to 5 millimeters; 
 and wherein: 
 at least one of the head and the distal portion of the conduit comprises an exposed surface of exposed material, the exposed surface having an average roughness (Ra) in a range of from 1 nanometer to 200 nanometers; 
 the Ra is in a range of from 1 nanometer to 50 nanometers over a continuous surface area of at least 2 square millimeters on the head; and 
 the implant device comprises an antimicrobial agent exposed at a said exposed surface, wherein the antimicrobial agent comprises an antimicrobial peptide or a member selected from the group consisting of silver, poly(ethylene oxide), polyethylene glycol and combinations thereof. 
 
     
     
       4. A method of making a paranasal sinus access implant device, the method comprising:
 providing a preliminary form made of a first material and including a preliminary head structure and a preliminary conduit structure; and 
 forming a skin portion including at least one second material, the skin portion supported by one or both of the preliminary head structure and the preliminary conduit structure, wherein:
 the skin portion has a depth below the exposed surface in a range of from 10 microns to 200 microns; and 
 the skin portion comprises an exposed surface of an exposed said second material, the exposed surface having an average roughness (Ra) in a range of from 1 to 35 nanometers; 
 
 and wherein the implant device comprises, after the forming:
 a proximal end at a first longitudinal end of the device to be disposed in the lacrimal apparatus when the device is implanted and a distal end at a second longitudinal end of the device to be disposed in the paranasal sinus when the device is implanted; 
 a length longitudinally along the implant device between the proximal end and the distal end in a range of from 8 millimeters to 50 millimeters; 
 a conduit, including the preliminary conduit structure, located between the proximal end and distal end, to be disposed through a fistula between the lacrimal apparatus and the paranasal sinus when the device is implanted, the conduit comprising a distal portion to be disposed in the paranasal sinus when the implant device is implanted; 
 a head, including the preliminary head structure, located proximal of the conduit, to be disposed in the lacrimal apparatus when the device is implanted; 
 an internal passage through the head and the conduit, to provide a fluid communication path between the lacrimal apparatus and the paranasal sinus when the device is implanted, the internal passage having a width through at least a portion of the conduit in a range of from 0.25 millimeter to 5 millimeters; and 
 the skin portion with the said exposed surface of an exposed said second material on one or both of the head and the conduit.